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A Study on the Efficacy of Androgen Deprivation Therapy Combined With Anti-PD-1 Therapy in Advanced Lung Cancer

NCT06512207 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-09

No results posted yet for this study

Summary

Androgen Deprivation Therapy (ADT) triggers thymic revitalization and increases thymic output, enhancing baseline anti-tumor immunity and responses to immunotherapies. Anti-tumor synergism has been identified by combining ADT with anti-PD-1 immunotherapy for androgen-independent tumors. This study is to investigate the combination of Leuprorelin ADT and Sintilimab (anti-PD-1) therapy in patients with advanced lung cancer.

Conditions

  • NSCLC, Stage III
  • NSCLC, Stage IV

Interventions

DRUG

Leuprorelin acetate + Sintilimab

Leuprolide, an FDA-approved GnRH agonist, reduces sex hormone production and is widely used in clinical practice.

DRUG

Sintilimab

PD-1 inhibitor

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Jinzhou Medical University

    lead OTHER

Principal Investigators

  • Yu Zhang, Professor · Jinzhou Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-03
Primary Completion
2025-12-31
Completion
2026-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06512207 on ClinicalTrials.gov